Application 078203

Type: ANDA
Sponsor: LEADING PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LORAZEPAM	LORAZEPAM	TABLET;ORAL	0.5MG	No	No
002	LORAZEPAM	LORAZEPAM	TABLET;ORAL	1MG	No	No
003	LORAZEPAM	LORAZEPAM	TABLET;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078203-001	LORAZEPAM	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30
A078203-002	LORAZEPAM	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30
A078203-003	LORAZEPAM	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078203-001	AB
A078203-002	AB
A078203-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078203-002	LORAZEPAM	1MG	TABLET / ORAL	AB	2007-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078203-003	LORAZEPAM	2MG	TABLET / ORAL	AB	2007-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-001	LORAZEPAM	0.5MG	TABLET / ORAL	AB	2007-07-30	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A078203-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078203-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078203-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078203-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078203-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078203-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078203-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078203-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078203-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078203-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078203-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078203-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078203-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078203-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078203-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078203-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078203-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078203-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078203-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078203-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078203-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078203-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078203-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078203-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078203-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078203-001	AB	1	`79d66fd596c7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	ba34ddd2-9a47-48bf-8e55-f05e9085e5a8	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203 ndc (product): 71335-1467
Lorazepam	LORAZEPAM	Bryant Ranch Prepack	8e3d44fb-24b7-4552-9e95-de3bf871a88b	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203 ndc (product): 71335-0655
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	973eff80-b2cd-42ca-8e88-e0151e691e59	2024-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203 ndc (product): 71610-255
Lorazepam	LORAZEPAM	Clinical Solutions Wholesale, LLC	fdc11b95-2233-42b4-b5f3-9390b5e9e1b2	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	Leading Pharma, LLC	5ca13415-4b77-4131-a9d2-6db26bc49167	2023-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	Asclemed USA, Inc.	91da80c8-3162-43f0-b53e-897070b26a54	2023-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	8df3eed3-c936-4772-ab08-574c54dd8bf5	2023-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203 ndc (product): 71610-122
Lorazepam	LORAZEPAM	Proficient Rx LP	73bf2b31-5c7e-4b3a-9e97-8304931510b0	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203 ndc (product): 71205-235
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	e83ae439-3fa5-453f-9073-4bf8c797df47	2019-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203 ndc (product): 71610-008
Lorazepam	LORAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f75	2018-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078203 application number: ANDA078203 ndc (product): 71610-178

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 3 of 3 · 188 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-2442	Lorazepam	Lorazepam	REMEDYREPACK INC.	ANDA	Current
70518-2442	Lorazepam	Lorazepam	REMEDYREPACK INC.	ANDA	Current
70518-2442	Lorazepam	Lorazepam	REMEDYREPACK INC.	ANDA	Current
71205-166	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71205-166	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71205-235	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71205-235	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71205-235	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71205-235	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71205-235	Lorazepam	Lorazepam	Proficient Rx LP	ANDA	Current
71335-0329	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-0329	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-0329	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-0329	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-0655	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-0655	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-0655	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-0655	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1467	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71335-1467	Lorazepam	Lorazepam	Bryant Ranch Prepack	ANDA	Current
71610-008	Lorazepam	Lorazepam	Aphena Pharma Solutions -	ANDA	Current
71610-008	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-122	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-178	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-225	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-255	Lorazepam	Lorazepam	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72789-197	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-197	Lorazepam	Lorazepam	PD-Rx Pharmaceuticals, Inc.	ANDA	Current